Biologics

Cruz, Others Question FDA on Covid-19 Vaccines for Babies

David McFarland

— 3 min read
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Some 18 members of Congress led by Sen. Ted Cruz (R-TX) have written to FDA commissioner Robert Califf and the agency’s Vaccines and Related Biological Products Advisory Committee with questions about emergency use authorizations (EUA) for Covid-19 vaccines in children under age 5. A statement (contains a link to the letter) from Cruz says before FDA approves an EUA for a children’s vaccine, “parents should be able to see the data and paperwork they would use to justify the decision. This is the least FDA can do for families in Texas and across the country so parents can make the best decisions for their children.”

The lawmakers pose these questions: 

  •         the reason has FDA been so slow to release the hundreds of thousands of pages of data from pre-approval manufacturer studies, post-approval adverse events data, and other post-approval manufacturer data submitted to FDA as required by law;
  •         what FDA is doing to expedite the release of the data and when it will all be released;
  •         if FDA were to approve Covid vaccines for children under age 5, whether it will release to the public within 14 days the data that were the basis for approval and if not, why not, and when will they be released;
  •         when FDA and the Centers for Disease Control and Prevention will provide the public with more details on children who have had the most serious adverse outcomes from Covid-19 infections;
  •         the cardiac risk factor in administering EUA Covid vaccines to children;
  •         the reason FDA recently lowered the efficacy bar for Covid vaccines for younger children;
  •         the evidence, if any, FDA has that “immunobridging” is an adequate surrogate to the disease prevention metrics used for previous EUAs;
  •         whether administering Covid vaccines to young children could predispose them to increased risk from future novel Covid variants;
  •         the studies FDA has relied on when examining the possibility of antibody-dependent enhancement resulting from EUA Covid vaccines and whether the agency can affirm with 100% certainty that it is not a risk factor for children receiving the vaccine;
  •         an estimate of the number of lives of those age 5 and under that FDA believes will be saved in the next year if the vaccine is approved and widely used;
  •         an estimate of the cost of administering the vaccine in this age group;
  •         the percentage of seropositivity in children in various age groups that FDA uses to demonstrate herd immunity;
  •         the number of children age 5 and under with preexisting medical conditions who have died from Covid or its variants;
  •         the number of healthy children age 5 and under without preexisting medical conditions who have died from Covid and its variants;
  •         the number of children age 5 and under with preexisting conditions who have been hospitalized due to (not with) Covid or its variants;
  •         the number of healthy children age 5 and under without preexisting medical conditions who have been hospitalized due to (not with) Covid or its variants;
  •         the number of children age 5 and under with preexisting medical conditions who have required treatment due to Covid 19 or its variants;
  •         the number of healthy children age 5 and under without preexisting medical conditions who have required treatment for Covid and its variants; and
  •         the medical emergencies of children 0 to 4 years old that enable FDA to approve the Covid vaccine for children using a EUA.

 

“The data show that the risks of serious adverse outcomes for Covid for children 5 and under is very low, and as such the standard for evaluating EUA interventions must be very high,” the letter concludes.

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